Rejection Acute RenalNCT04292418
Predictors of Rejection in Pediatric Kidney Transplantation
An observational study of Rejection Acute Renal, run by Assiut University.
Trial summary
Renal transplantation is the best option among the end-stage renal disease (ESRD) treatment alternatives, It is also relatively less expensive than dialysis. Allograft rejection is a major issue in kidney transplantation. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Rejection Acute Renal
- What is being tested?
- Tacrolimus capsule , mycophenolic acid
- Type of treatment
- Pill or oral medicine
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2020to 1 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Paediatric living donor kidney transplant recipients (aged 1-18 years)
Who may be able to join
- Paediatric living donor kidney transplant recipients (aged 1-18 years)
- patients received standard triple drug immunosuppression consisting tacrolimus an antiproliferative drug [mycophenolate mofetil (MMF) and steroids
- recipients with biopsy proven acute rejection in the studied group.
Who cannot join
- patients on cyclosporine
- patients with active infection and dehydration
- Patients who received multiorgan transplantation Non cooperative patient will be excluded
Trial locations and contacts
No sites are listed yet.
About this study
Renal transplantation is the best option among the end-stage renal disease (ESRD) treatment alternatives, It is also relatively less expensive than dialysis. Allograft rejection is a major issue in kidney transplantation. Rejection is classified as acute or chronic, cellular or antibody-mediated.Children with kidney transplants require life-long immunosuppressive therapy to prevent rejection of the allograft
Read the detailed description
The most common medication regimen in the United States includes the combination of corticosteroid (eg, prednisone), a calcineurin inhibitor (or CNI, most commonly tacrolimus), and an antimetabolite such as mycophenolate mofetil (MMF). Cyclosporine and azathioprine are less commonly used for maintenance immunosuppression Tacrolimus level is a main maintenance immunosuppressant in kidney transplantation .In the early days of posttransplant period, hematocrit concentrations are generally low and increase significantly as patient recovers. Because tacrolimus binds strongly to erythrocytes in systemic circulation, the effect of hematocrit on distribution of tacrolimus is important for the methods used to measure tacrolimus concentrations ,hematocrit correction could be a step towards improvement of tacrolimus dose individualization Thearputic drug monitoring of MPA has been proposed to optimize drug dosage avoiding potential hematologic and digestive side effects .MPA monitoring is generally based on the determination of the plasma MPA trough concentration (C0) .
- Conditions
- Rejection Acute Renal
- Being tested
- Tacrolimus capsule , mycophenolic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus capsule , mycophenolic acidDrug
measuring tacrolimus level by elisa test then correlated with hematocrit level measuring mycophenolic acid by elisa test for study group 1 and study group 2
| Study group | Role | What they receive |
|---|---|---|
| study group 1 | (rejector group )include Paediatric living donor kidney transplant recipients (aged 4-18 years) at least 35 child recieving standard triple drug immunosuppression consisting tacrolimus an antiproliferative drug [mycophenolate mofetil (MMF) and steroids, with biopsy proven acute rejection in the study group 1 measuring tacrolimus level by elisa test then correlated with hematocrit level measuring mycophenolic acid by elisa test Receives: Drug: Tacrolimus capsule , mycophenolic acid | |
| study group 2 | the second group (non rejector group ) include Paediatric living donor kidney transplant recipients (aged 4-18 years) recieving standard triple drug immunosuppression consisting tacrolimus an antiproliferative drug [mycophenolate mofetil (MMF) and steroids, with biopsy proven acute rejection in the studied group at least 35 child measuring tacrolimus level by elisa test then correlated with hematocrit level measuring mycophenolic acid by elisa test in the study group 2 Receives: Drug: Tacrolimus capsule , mycophenolic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
predictors of rejection
detect the potentially predictors of rejection in pediatric kidney transplant recipient
Measured: 2 year
Secondary outcomes (1)
measure corrected tacrolimus level and mycophenolic acid
detect the role of corrected tacrolimus level in dose adjustment for better control of immunosuppressive therapy detect the role of neutrophil to lymphocytic ratio in prediction of kidney rejection Role of mycophenolic acid monitoring in prevention of rejection
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start1 May 2020 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Rejection Acute RenalStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Khalifa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292418
- Sponsor's protocol ID
- PKTX
- Status last verified
- Feb 2020
- First submitted
- 29 Feb 2020
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bulut IK, Taner S, Keskinoglu A, Sezer TO, Kabasakal C. Pediatric Kidney Transplantation in Patients With Urologic Anomalies. Transplant Proc. 2019 Sep;51(7):2257-2261. doi: 10.1016/j.transproceed.2019.01.155. Epub 2019 Aug 7.
PubMed 31400969Tamain M, Sayegh J, Lionet A, Grimbert P, Philipponnet C, Hazzan M, Augusto JF, Buchler M, Merlin E, Kosmadakis G, Tiple A, Pereira B, Garrouste C, Heng AE. Extracorporeal photopheresis for the treatment of graft rejection in 33 adult kidney transplant recipients. Transfus Apher Sci. 2019 Aug;58(4):515-524. doi: 10.1016/j.transci.2019.06.031. Epub 2019 Jul 22.
PubMed 31383541Park WY, Paek JH, Jin K, Park SB, Han S. Long-term Clinical Significance of Tacrolimus Trough Level at the Early Period After Kidney Transplantation. Transplant Proc. 2019 Oct;51(8):2643-2647. doi: 10.1016/j.transproceed.2019.03.065. Epub 2019 Aug 30.
PubMed 31477420Akbas SH, Ozdem S, Caglar S, Tuncer M, Gurkan A, Yucetin L, Senol Y, Demirbas A, Gultekin M, Ersoy FF, Akaydin M. Effects of some hematological parameters on whole blood tacrolimus concentration measured by two immunoassay-based analytical methods. Clin Biochem. 2005 Jun;38(6):552-7. doi: 10.1016/j.clinbiochem.2005.02.011.
PubMed 15885236Krischock LA, van Stralen KJ, Verrina E, Tizard EJ, Bonthuis M, Reusz G, Hussain FK, Jankauskiene A, Novljan G, Spasojevic-Dimitrijeva B, Podracka L, Zaller V, Jager KJ, Schaefer F; ESPN/ERA-EDTA Registry. Anemia in children following renal transplantation-results from the ESPN/ERA-EDTA Registry. Pediatr Nephrol. 2016 Feb;31(2):325-33. doi: 10.1007/s00467-015-3201-8. Epub 2015 Sep 18.
PubMed 26385862Chinnakotla S, Verghese P, Chavers B, Rheault MN, Kirchner V, Dunn T, Kashtan C, Nevins T, Mauer M, Pruett T; MNUM Pediatric Transplant Program. Outcomes and Risk Factors for Graft Loss: Lessons Learned from 1,056 Pediatric Kidney Transplants at the University of Minnesota. J Am Coll Surg. 2017 Apr;224(4):473-486. doi: 10.1016/j.jamcollsurg.2016.12.027. Epub 2017 Feb 27.
PubMed 28254584Schijvens AM, van Hesteren FHS, Cornelissen EAM, Bootsma-Robroeks CMHHT, Bruggemann RJM, Burger DM, de Wildt SN, Schreuder MF, Ter Heine R. The potential impact of hematocrit correction on evaluation of tacrolimus target exposure in pediatric kidney transplant patients. Pediatr Nephrol. 2019 Mar;34(3):507-515. doi: 10.1007/s00467-018-4117-x. Epub 2018 Oct 30.
PubMed 30374607Limsrichamrern S, Chanapul C, Mahawithitwong P, Sirivatanauksorn Y, Kositamongkol P, Asavakarn S, Tovikkai C, Dumronggittigule W. Correlation of Hematocrit and Tacrolimus Level in Liver Transplant Recipients. Transplant Proc. 2016 May;48(4):1176-8. doi: 10.1016/j.transproceed.2015.12.096.
PubMed 27320581
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Rejection in Pediatric Kidney Transplantation
- ClinicalTrials.gov ID
- NCT04292418
- Acronym / sponsor ID
- PKTX
- Conditions
- Rejection Acute Renal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Renal transplantation is the best option among the end-stage renal disease (ESRD) treatment alternatives, It is also relatively less expensive than dialysis. Allograft rejection is a major issue in kidney transplantation. Rejection is classified as acute or chronic, cellular or antibody-mediated.Children with kidney transplants require life-long immunosuppressive therapy to prevent rejection of the allograft
Detailed description
The most common medication regimen in the United States includes the combination of corticosteroid (eg, prednisone), a calcineurin inhibitor (or CNI, most commonly tacrolimus), and an antimetabolite such as mycophenolate mofetil (MMF). Cyclosporine and azathioprine are less commonly used for maintenance immunosuppression Tacrolimus level is a main maintenance immunosuppressant in kidney transplantation .In the early days of posttransplant period, hematocrit concentrations are generally low and increase significantly as patient recovers. Because tacrolimus binds strongly to erythrocytes in systemic circulation, the effect of hematocrit on distribution of tacrolimus is important for the methods used to measure tacrolimus concentrations ,hematocrit correction could be a step towards improvement of tacrolimus dose individualization Thearputic drug monitoring of MPA has been proposed to optimize drug dosage avoiding potential hematologic and digestive side effects .MPA monitoring is generally based on the determination of the plasma MPA trough concentration (C0) .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group 1 | – | Drug: Tacrolimus capsule , mycophenolic acid(rejector group )include Paediatric living donor kidney transplant recipients (aged 4-18 years) at least 35 child recieving standard triple drug immunosuppression consisting tacrolimus an antiproliferative drug [mycophenolate mofetil (MMF) and steroids, with biopsy proven acute rejection in the study group 1 measuring tacrolimus level by elisa test then correlated with hematocrit level measuring mycophenolic acid by elisa test |
| study group 2 | – | Drug: Tacrolimus capsule , mycophenolic acidthe second group (non rejector group ) include Paediatric living donor kidney transplant recipients (aged 4-18 years) recieving standard triple drug immunosuppression consisting tacrolimus an antiproliferative drug [mycophenolate mofetil (MMF) and steroids, with biopsy proven acute rejection in the studied group at least 35 child measuring tacrolimus level by elisa test then correlated with hematocrit level measuring mycophenolic acid by elisa test in the study group 2 |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Paediatric living donor kidney transplant recipients (aged 1-18 years)
Key inclusion criteria (3 listed)
- Paediatric living donor kidney transplant recipients (aged 1-18 years)
- patients received standard triple drug immunosuppression consisting tacrolimus an antiproliferative drug [mycophenolate mofetil (MMF) and steroids
- recipients with biopsy proven acute rejection in the studied group.
Key exclusion criteria (3 listed)
- patients on cyclosporine
- patients with active infection and dehydration
- Patients who received multiorgan transplantation Non cooperative patient will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tacrolimus capsule , mycophenolic acidmeasuring tacrolimus level by elisa test then correlated with hematocrit level measuring mycophenolic acid by elisa test for study group 1 and study group 2 | Drug | study group 1, study group 2 |
Primary outcome
predictors of rejection
Time frame: 2 year
detect the potentially predictors of rejection in pediatric kidney transplant recipient
1 secondary outcome
measure corrected tacrolimus level and mycophenolic acid
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Results publication: PubMed 31400969Bulut IK, Taner S, Keskinoglu A, Sezer TO, Kabasakal C. Pediatric Kidney Transplantation in Patients With Urologic Anomalies. Transplant Proc. 2019 Sep;51(7):2257-2261. doi: 10.1016/j.transproceed.2019.01.155. Epub 2019 Aug 7.
- Results publication: PubMed 31383541Tamain M, Sayegh J, Lionet A, Grimbert P, Philipponnet C, Hazzan M, Augusto JF, Buchler M, Merlin E, Kosmadakis G, Tiple A, Pereira B, Garrouste C, Heng AE. Extracorporeal photopheresis for the treatment of graft rejection in 33 adult kidney transplant recipients. Transfus Apher Sci. 2019 Aug;58(4):515-524. doi: 10.1016/j.transci.2019.06.031. Epub 2019 Jul 22.
- Results publication: PubMed 31477420Park WY, Paek JH, Jin K, Park SB, Han S. Long-term Clinical Significance of Tacrolimus Trough Level at the Early Period After Kidney Transplantation. Transplant Proc. 2019 Oct;51(8):2643-2647. doi: 10.1016/j.transproceed.2019.03.065. Epub 2019 Aug 30.
- Results publication: PubMed 15885236Akbas SH, Ozdem S, Caglar S, Tuncer M, Gurkan A, Yucetin L, Senol Y, Demirbas A, Gultekin M, Ersoy FF, Akaydin M. Effects of some hematological parameters on whole blood tacrolimus concentration measured by two immunoassay-based analytical methods. Clin Biochem. 2005 Jun;38(6):552-7. doi: 10.1016/j.clinbiochem.2005.02.011.
- Results publication: PubMed 26385862Krischock LA, van Stralen KJ, Verrina E, Tizard EJ, Bonthuis M, Reusz G, Hussain FK, Jankauskiene A, Novljan G, Spasojevic-Dimitrijeva B, Podracka L, Zaller V, Jager KJ, Schaefer F; ESPN/ERA-EDTA Registry. Anemia in children following renal transplantation-results from the ESPN/ERA-EDTA Registry. Pediatr Nephrol. 2016 Feb;31(2):325-33. doi: 10.1007/s00467-015-3201-8. Epub 2015 Sep 18.
- Results publication: PubMed 28254584Chinnakotla S, Verghese P, Chavers B, Rheault MN, Kirchner V, Dunn T, Kashtan C, Nevins T, Mauer M, Pruett T; MNUM Pediatric Transplant Program. Outcomes and Risk Factors for Graft Loss: Lessons Learned from 1,056 Pediatric Kidney Transplants at the University of Minnesota. J Am Coll Surg. 2017 Apr;224(4):473-486. doi: 10.1016/j.jamcollsurg.2016.12.027. Epub 2017 Feb 27.
- Results publication: PubMed 30374607Schijvens AM, van Hesteren FHS, Cornelissen EAM, Bootsma-Robroeks CMHHT, Bruggemann RJM, Burger DM, de Wildt SN, Schreuder MF, Ter Heine R. The potential impact of hematocrit correction on evaluation of tacrolimus target exposure in pediatric kidney transplant patients. Pediatr Nephrol. 2019 Mar;34(3):507-515. doi: 10.1007/s00467-018-4117-x. Epub 2018 Oct 30.
- Results publication: PubMed 27320581Limsrichamrern S, Chanapul C, Mahawithitwong P, Sirivatanauksorn Y, Kositamongkol P, Asavakarn S, Tovikkai C, Dumronggittigule W. Correlation of Hematocrit and Tacrolimus Level in Liver Transplant Recipients. Transplant Proc. 2016 May;48(4):1176-8. doi: 10.1016/j.transproceed.2015.12.096.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Rejection Acute Renal, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aya Khalifa, master degree (00201016228446, dr.ayaahmedkhlifa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
predictors of rejection (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04292418, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.